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Oratecan
Oratecan is a Small molecule drug developed by Athenex, Inc.. It is currently in Phase 1 development. Also known as: Camptosar, HM30181.
Oratecan is being studied in clinical trials for the treatment of advanced solid tumors and advanced cancer. It has been tested in combination with Capecitabine in a Phase I clinical trial to determine its maximum tolerated dose and assess its safety.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Oratecan |
|---|---|
| Also known as | Camptosar, HM30181 |
| Sponsor | Athenex, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies (PHASE1)
- Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oratecan CI brief — competitive landscape report
- Oratecan updates RSS · CI watch RSS
- Athenex, Inc. portfolio CI
Frequently asked questions about Oratecan
What is Oratecan?
Who makes Oratecan?
Is Oratecan also known as anything else?
What development phase is Oratecan in?
Related
- Manufacturer: Athenex, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Camptosar, HM30181
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing